We suspect a good mix of, patient, business development, project management, quality assurance, pharmaceutical technology and probably a regulatory affairs hat!

Developing a product and then maintaining the marketing authorisation post-approval is like walking through a hall of mirrors, it distorts your perspective, priorities and sometimes your resources, it can be an very expensive walk if you take the wrong turn.

We use the Two Hats principle, i.e. we try to help you wear the hat you need to concentrate on, whilst using our second hat of practical ethical regulatory science advice based on common sense and thus help you return to your priorities.

We are not a regulatory consultancy that claims to be able to do everything for everyone. We are a co-operative offering niche regulatory consultancy services for those companies and non-profit organisations that like a mix of creative solutions based on common (scientific) sense at a fair price.

If we can not help you, we will inform you and where possible recommend someone who might be able to help, because our guiding business principles are based on integrity, transparency and simplicity.

Two Hats Regulatory Science strives to:

  1. Provide clients with honest, pragmatic regulatory advice & support based on scientific rationale and common sense,
  2. Stay patient focused, whilst fusing your combined manufacturing, non-clinical & clinical expertise with ours,
  3. Be a small team of ethically motivated entrepreneurs, helping your business stay in business,
  4. Be open & transparent about costs, depending on consultant, we charge a flat rate of  either €75 or €100/hour, (excluding 19% VAT and no complicated discounts),
  5. Manage our natural & human resources responsibly & effectively to reduce time, waste & costs,
  6. Mentoring & training of members of staff to help bring out the best in them,
  7. Create a fun, healthy and creative working environment.
  8. Remember we are only human and therefore not perfect!

        We aim not to accept projects: